Suzhou Evopoint Biosciences Co., Ltd. (referred to as "Evopoint" or "the company") announced today that it has submitted the Pre-NDA application for its investigational first-in-class drug, Funobactam/Imipenem/Cilastatin, to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. The drug is poised to become the world's first broad-spectrum novel β-lactam/β-lactamase inhibitor (BL/BLI) with potent antimicrobial activity against the three major carbapenem-resistant gram-negative bacilli (CRO). Detailed research data will be presented at academic conferences or published in scientific journals.
The application is based on the excellent results of the XNW4107-302 study. This study is a prospective, international, multicenter, double-blind, randomized, positive-controlled Phase III registration trial aimed to evaluate the efficacy, safety, and tolerability of Funobactam/Imipenem/Cilastatin compared to intravenous Recarbrio (Relebactam/Imipenem/Cilastatin) in the treatment of hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) caused by Gram-negative bacteria.
A total of 449 subjects were enrolled in the study. The results demonstrated that Funobactam/Imipenem/Cilastatin met the non-inferiority criteria for the primary endpoint - 14-day all-cause mortality. Furthermore, Funobactam/Imipenem/Cilastatin demonstrated superior results compared to the control treatment in terms of clinical treatment success rate and multidrug-resistant microorganism clearance rate. Additionally, Funobactam/Imipenem/Cilastatin exhibited favorable tolerability and showed satisfactory safety profile throughout the clinical trial.
Funobactam/Imipenem/Ceftazidime is effective against three major carbapenem-resistant gram-negative bacilli (CROs)
Bacterial resistance is a major global public health challenge. The World Health Organization (WHO) has classified Carbapenem-resistant Acinetobacter Baumannii (CRAB), Carbapenem-resistant Pseudomonas Aeruginosa (CRPA), and Carbapenem-resistant Enterobacteriaceae (CRE) as highly threatening resistant bacteria; according to the China Antimicrobial Resistance Surveillance System (CARSS) results for the first half of 2024 in China, the detection rate of carbapenem-resistant gram-negative bacilli remains high. Nevertheless, the development of new antimicrobial drugs lags behind the evolution of bacterial resistance, which makes clinical treatment options cornered.
Evopoint aspires to tackle this issue since its inception. Funobactam(XNW4107) specifically targets the antimicrobial resistance, addressing the ineffectiveness of existing β-lactamase inhibitors against CRE, CRPA, and CRAB.
"Funobactam is a novel β-lactamase inhibitor developed independently by Evopoint. When used in combination with imipenem and cilastatin, the β-lactamase inhibitor has shown good antibacterial activity against the three carbapenem-resistant bacteria that need to be addressed urgently, which makes it have a wide range of applications in the future and great market potential. Funobactam has completed the Pre-NDA application, marking a crucial step forward in providing superior treatment solutions for global patients. We look forward to working closely with regulatory authorities to bring this novel drug to patients in need as soon as possible."
About HABP and VABP
In hospital-acquired infectious diseases, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are among the most common diseases. Gram-negative bacilli, including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens in HABP/VABP, with the emergence of multidrug-resistant strains, especially carbapenem-resistant strains, leading to an increase in both clinical treatment failure and mortality rates, making it a focus of global concern. Carbapenems are usually the last line of antibiotics for treating severe infections caused by multidrug-resistant organisms, so clinical treatment options for infections with carbapenem-resistant organisms are often limited. Given the current serious situation of antibiotic resistance, especially the widespread presence of Acinetobacter baumannii (CRAB) , it is believed that there will be fairly broad market prospects for future use of Funobactam.
